Drugs / BT5528
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04075175 | Apr → Oct 2019 | diphtheria | MassBiologics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04180371 | Nov 2019 → Jul 2026 overdue | gastroesophageal cancer, head and neck cancer, non-small cell lung carcinoma, ovarian cancer +2 | BicycleTx Limited | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07681674 | Aug 2026 → May 2030 expected | cancer | BicycleTx Limited | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07450859 | Mar 2026 → Mar 2029 expected | pancreatic ductal adenocarcinoma | BicycleTx Limited | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-04-20 | BicycleTx Limited | Results Bicycle Therapeutics Provides Update on Nuzefatide Pevedotin and EphA2 Pipeline at the AACR Annual Meeting 2026 bicycletherapeutics.com ↗
Phase 1 combination data of 6.5mg/m2 Q2W nuzefatide pevedotin plus nivolumab demonstrate an encouraging preliminary efficacy profile with a differentiated tolerability profile in previously treated metastatic urothelial cancer |
| 2024-09-14 | BicycleTx Limited | Results Bicycle Therapeutics Presents Updated Clinical Results Across Oncology Pipeline at ESMO Congress 2024 bicycletherapeutics.com ↗
EphA2-targeting BT5528 demonstrated an emerging differentiated safety profile and antitumor activity in patients with advanced solid tumors, including a 45% ORR in mUC 6.5 mg/m2 every two weeks dose expansion cohort |
| 2024-05-23 | BicycleTx Limited | Regulatory Bicycle Therapeutics to Present Pharmacokinetic and Safety Evaluation of Lead BTC® Molecules in Phase 1/2 Trials at the 2024 ASCO Annual Meeting bicycletherapeutics.com ↗
FDA Fast Track Designation Granted to BT5528 for the treatment of patients with metastatic urothelial cancer |
| 2022-09-07 | BicycleTx Limited | Results Bicycle Therapeutics Announces BT5528 Phase I Dose Escalation Results in Patients with Advanced Solid Tumors bicycletherapeutics.com ↗
Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced Phase I dose escalation top-line results from its Phase I/II trial of BT5528, a BTC targeting EphA2, in patients with advanced solid tumors. |
| 2021-10-07 | BicycleTx Limited | Results Bicycle Therapeutics Announces Interim BT5528 Phase I Clinical Trial Results and Preliminary Results from Ongoing BT8009 Phase I Clinical Trial bicycletherapeutics.com ↗
Based on the Phase I results, Bicycle has established an RP2D range. |
| 2021-01-14 | BicycleTx Limited | Results Bicycle Therapeutics Announces Pipeline Progress Update bicycletherapeutics.com ↗
BT5528 has been tolerated up to 8.5mg/m2 weekly, which Bicycle believes, based on pre-clinical studies, is toward the top of the therapeutic range, with transient neutropenia observed at that dose. |
| 2020-06-22 | BicycleTx Limited | Results Bicycle Therapeutics Presents New Translational Data for BT5528 and Preclinical Data for Tumor-targeted Immune Cell Agonists at AACR Virtual Annual Meeting II bicycletherapeutics.com ↗
New translational data for BT5528, a second-generation Bicycle Toxin Conjugate (BTC) that targets EphA2, describe the development of Bicycle’s proprietary IHC assay. |
| 2020-05-12 | BicycleTx Limited | Results Bicycle Therapeutics Announces Publication of BT5528 Mechanism of Action in AACR Journal Molecular Cancer Therapeutics bicycletherapeutics.com ↗
The preclinical data for BT5528 published in Molecular Cancer Therapeutics suggest that the key features of Bicycles, such as their low molecular weight, short systemic half-life and renal route of elimination, can result in a therapeutic candidate with an in vivo pharmacokinetic profile that yields a wider preclinical therapeutic index than that of a comparator ADC. |
| 2020-04-07 | BicycleTx Limited | Results Bicycle Therapeutics Announces Pipeline Progress Update bicycletherapeutics.com ↗
Dosing complete in second cohort of Phase I dose escalation for BT5528—all doses administered in Phase I to date appear tolerable |
| 2019-03-29 | BicycleTx Limited | Results Bicycle Therapeutics to Present Preclinical Data on EphA2 and Nectin-4 Bicycle Toxin Conjugate Programs, as well as a CD137 Immune Oncology Program, at the American Association for Cancer Research Annual Meeting bicycletherapeutics.com ↗
Preclinical data from both our BT5528 and BT8009 programs show target-dependent anti-tumor activity across a range of EphA2-expressing and Nectin-4-expressing cancer models, respectively, and we’re proud that AACR has chosen to highlight our work. |
All press releases naming this drug 17 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BT5528 | “This is a Phase 2 study for nuzefatide pevedotin (BT5528) in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has...” NCT07450859 ↗ |
| Known as | nuzefatide pevedotin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07450859 ↗ |
| Known as | S315 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04075175 ↗ |
| Action | Inhibit | “S315 is a fully human, monoclonal immunoglobulin G1 neutralizing antibody, specific to the receptor-binding domain of diphtheria toxin.” PMID 39570031 ↗ Sep 2025 |
| Modality | Monoclonal antibody | “S315 is a fully human, monoclonal immunoglobulin G1 neutralizing antibody, specific to the receptor-binding domain of diphtheria toxin.” PMID 39570031 ↗ Sep 2025 |
| Route | Intravenous | “single intravenous infusions of S315” PMID 39570031 ↗ Sep 2025 |
| Target | EPHA2 | “binds to EphA2” NCT04180371 ↗ |